510(k) · Cleared
Cleared.Decimal Photon Block
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
.Decimal, Inc. · IXI Block, Beam-Shaping, Radiation Therapy
Cleared on Nov 21, 2012 as substantially equivalent to K111759 (.Decimal, Inc., 2011) after a 54-day review. Its family tree reaches back 1 generation to 2011.
- Decided
- Nov 21, 2012
- Review
- 54 days
- Class
- Class II
- Product code
- IXI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K111759 (2011). No later device cites it as a predicate yet.
- Root · 1 generation backK111759 .Decimal Electron Aperture.Decimal, Inc. · 2011
- This deviceK123015 .Decimal Photon Block.Decimal, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K111759 | .Decimal Electron Aperture | .Decimal, Inc. | 2011 | — |
| 0 (this device) | K123015 | .Decimal Photon Block | .Decimal, Inc. | 2012 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IXI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IXI device
- #1 K253025 Ricoh 3D for Healthcare Bolusscore 12.9 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K111759 | .Decimal Electron ApertureSummary page 2…section 12 of this submittal. Predicate Device(s): decimal Electron Aperture (KI 111759), .decimal Inc. Intended Use: .decimal's Photon Block manufacturing service manufactures Photon Bl… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All IXI devicesIXI Block, Beam-Shaping, Radiation Therapy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · IXI
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · IXI
90in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IXI
2in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IXI
1in 2016
MAUDE reports naming product code IXI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 3 | 78 | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 2 | — | 1 | 28 |
| 2012 | 1 | — | 1 | 3 |
| 2013 | 3 | 90 | 2 | 2 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
In IMRT therapy for cancer, a photon beam is aimed at the cancerous tissue using a linear accelerator. The linear accelerator is rotated around the patient while the patient lies on a treatment table; the linear accelerator consists of the gantry, which rotates around the patient. The gantry contains a collimator, which points at pre-determined positions to maximize efficiency and dose delivery to the tumor volume. Each gantry angle, or "port", requires…
Read the full statement (152 words)
In IMRT therapy for cancer, a photon beam is aimed at the cancerous tissue using a linear accelerator. The linear accelerator is rotated around the patient while the patient lies on a treatment table; the linear accelerator consists of the gantry, which rotates around the patient. The gantry contains a collimator, which points at pre-determined positions to maximize efficiency and dose delivery to the tumor volume. Each gantry angle, or "port", requires custom-made, beam modifying, patient specific devices called: Photon Block.
The Photon Block is inserted into the gantry's collimator to shape and focus the beanm as it exits the gantry en route to the targeted area. The photon block is also called a cerrobend block, which defines the area that is to be treated with the photon beam. Photon Blocks are generated out of the treatment planning system or physician's specifications and are unique to each patient and each gantry angle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123015 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123015: .Decimal Photon Block.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123015
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026